Insulin is a naturally occurring hormone made by the pancreas that helps our body use or store the glucose (sugar) it gets from food. For people with diabetes, either the pancreas does not make enough insulin to meet the body's requirements, or the body cannot properly use the insulin that is made. As a result, glucose cannot be used or stored properly and accumulates in the bloodstream. Insulin injected under the skin helps to lower blood glucose levels.

There are many different types of insulin and they are absorbed at different rates and work for varying periods of time. Insulin aspart mix contains insulin aspart and insulin aspart protamine crystals. Insulin aspart is a rapid-acting insulin. It takes 10 to 15 minutes to begin working after the injection, has its maximum effect between 60 and 180 minutes, and stops working after 3 to 5 hours.

Insulin aspart protamine crystals are absorbed more slowly than insulin aspart, lowering the blood glucose levels over a prolonged period of time. When mixed together they start working within 10 to 20 minutes following injection, reach a maximum effect between 1 to 4 hours after injection and lasts up to 24 hours.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it. Never share your pen with anyone else as you may transmit serious diseases.

Your required dose of insulin depends on how much natural insulin your pancreas is producing and how well your body is able to use the insulin. Your doctor or diabetes educator will determine the appropriate dose for you according to various lifestyle factors and the blood glucose values obtained while monitoring your blood glucose.

Your dose of insulin should be injected subcutaneously (under the skin) exactly as instructed by your doctor or diabetes educator. Do not inject insulin aspart mix into the vein and do not use insulin aspart mix in insulin infusion pumps. The dose of insulin is measured in international units (IU). Each mL of insulin contains 100 IU. Insulin aspart mix is injected under the skin not more than 5 to 10 minutes before the start of a meal. There are many variations of insulin dosing.

Insulin aspart mix is a white suspension available in cartridges. It is used in a special device that looks like a pen. The mixture should be uniformly white and cloudy. Do not use the insulin if you notice anything unusual in the appearance of the solution, such as a frosted appearance.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is very important that you use this medication exactly as prescribed by your doctor. The timing of insulin with respect to your meals is crucial to keeping blood glucose under control and preventing unwanted side effects. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Keep unopened cartridges of insulin in the refrigerator until needed. They may be used until the expiry date on the label. Never allow insulin to freeze. Insulin that is currently in use may be kept at room temperature for no more than 28 days and then discarded. Insulin must not be exposed to extremely hot temperatures or to sunlight. Keep insulin out of reach of children.

Each mL of sterile, uniform, white suspension contains insulin aspart (B28 asp regular human insulin analogue; 30% insulin aspart and 70% insulin aspart protamine crystals) 100 units. Nonmedicinal ingredients: glycerol, phenol, metacresol, zinc, disodium hydrogen phosphate dihydrate, sodium chloride, protamine sulfate, sodium hydroxide, hydrochloric acid, and water for injection.

Do not use this medication if you:

• are allergic to or have a suspected allergy to insulin or any ingredients of the medication
• have low blood glucose (hypoglycemia)

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• joint swelling
• redness, itching, or swelling at the site of the injection
• skin changes at injection site

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• lumps under the skin
• signs of low blood glucose:
• anxiety
• blurred vision
• confusion
• difficulty concentrating
• difficulty speaking
• dizziness
• drowsiness
• fast heartbeat
• headache
• hunger
• nausea
• nervousness
• numbness or tingling of the lips, fingers, or tongue
• sweating
• tiredness
• trembling
• weakness
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• rash or blisters all over the body
• seizures
• symptoms of a serious allergic reaction (e.g., swelling of the face or throat, difficulty breathing, wheezing, hives, or itchy skin rash)
• unconsciousness

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: If you notice signs of a serious allergic reaction (e.g., swelling of the face or throat, difficulty breathing, wheezing, or itchy skin rash), stop taking the medication and seek immediate medical attention. Reactions at the site of injection (redness, swelling, and itching) usually resolve within a few days or weeks.

Appearance of insulin: The contents of the vial of this insulin should be cloudy and white. Do not use the insulin if it looks lumpy or grainy, seems unusually thick, sticks to the bottle or vial, or appears discoloured. Do not use it if it contains crystals, if the bottle or vial looks frosted, or if the suspension remains clear after being rolled between your hands.

Changes at injection site: Fatty tissue under the skin at the injection site may shrink or thicken if you inject yourself too often at the same site. To help avoid this effect, change the site with each injection. Talk to your doctor or diabetes educator if you notice your skin pitting or thickening at the injection site.

Changes in insulin requirements: Many things can affect blood glucose levels and insulin requirements. These include:

• certain medical conditions (e.g., infections, thyroid conditions, or liver or kidney disease)
• certain medications that increase or decrease blood glucose levels
• diet
• exercise
• illness
• injury
• stress
• surgery
• travelling over time zones

It is important your doctor know your current health situation and any changes that may affect the amount of insulin you need. Blood glucose should be monitored regularly as recommended by your doctor or diabetes educator.

Diabetic identification: It is important to either wear a bracelet (or necklace) or carry a card indicating you have diabetes and are taking insulin.

Family and friends: Educate your family and friends about the signs and symptoms of hypoglycemia (low blood glucose). Keep a glucagon kit available and instruct them on its proper use in case you experience severe low blood glucose and you lose consciousness.

Low blood glucose (hypoglycemia): Hypoglycemia may occur if too much insulin is used, if meals are missed, or if you exercise more than usual. Symptoms of mild to moderate hypoglycemia may occur suddenly and can include cold sweat, nervousness or shakiness, fast heartbeat, headache, hunger, confusion, lightheadedness, weakness, and numbness or tingling of the tongue, lips, or fingers. Mild to moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. People taking insulin should always carry a quick source of sugar, such as hard candies, glucose tablets, juice, or regular soft drinks (not diet soft drinks).

Signs of severe hypoglycemia can include disorientation, loss of consciousness, and seizures. People who are unable to take sugar by mouth or who are unconscious may require an injection of glucagon or treatment with intravenous (into the vein) glucose.

Pregnancy: It is essential to maintain good blood glucose control throughout pregnancy. Insulin requirements usually decrease during the first trimester and increase during the second and third trimesters.

Breast-feeding: If you are breast-feeding, you may require adjustments in your insulin dose or diet. It is not known if insulin aspart mix passes into breast milk. If you are breast-feeding and are taking insulin aspart mix, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

There may be an interaction between insulin aspart mix and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since alcohol, caffeine, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.